FOR IMMEDIATE RELEASE:
March 18, 2020
Contact: Press@paul.senate.gov, 202-224-4343
WASHINGTON, D.C. – Yesterday, U.S. Senator and physician Rand Paul (R-KY) introduced S. 3512, the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020, to help make tests quickly and widely available in health emergencies by removing unnecessary government barriers that have drastically slowed the response to the novel coronavirus pandemic. Dr. Paul’s plan would help ensure labs could develop and use tests within days, providing a better opportunity to isolate, contain, and understand viruses.
“When we face a health emergency, government should trust academic, community, and public health labs to do what they are already trained and certified to do. With all of the debates about how government should respond, here’s one thing it can stop doing: piling counter-productive bureaucratic hurdles in the way of our medical professionals,” said Dr. Paul.
Generally, lab-developed testing procedures (LDPs), which are developed, validated, and performed inside the same laboratory, are regulated under the Clinical Laboratory Improvement Amendments (CLIA). With the January public health emergency declaration in place, however, government initially required all tests for the novel coronavirus to obtain an emergency use authorization (EUA) from the Food and Drug Administration (FDA) before they could be used on patients.
The FDA issued the Centers for Disease Control and Prevention (CDC) an EUA for its test kit on February 4, authorizing only public health labs and Department of Defense labs to use the test. But problems with the initial kit led to a weeks-long delay until the CDC issued a new one, with laboratories having to spend that critical time wrestling with bureaucratic approval in the EUA process in order to use their own tests, depleting needed resources.
While the FDA has issued multiple policy changes to address the issue and speed up the process, including increasing state authority, the missed time cannot be replaced.
Dr. Paul’s plan would institute a legislative fix that allows laboratories to follow the CLIA process even during public emergencies, helping prevent such delays and waste of time and money again.
You can read Dr. Paul’s VITAL Act of 2020 and you can find a summary of the bill below:
S. 3512 – Dr. Rand Paul’s Verified Innovative Testing in American Laboratories (VITAL) Act of 2020
• Clarifies that the Public Health Service Act governs all aspects of laboratory-developed testing procedures — including during a declared emergency.
• Requires the Centers for Medicare and Medicaid Services (CMS) to hold a public meeting to solicit recommendations on updating the regulations for the Clinical Laboratory Improvement Amendments (CLIA) within 90 days of enactment.
• Requires the Secretary of HHS to report to Congress, within 180 days of enactment, recommendations to update the Clinical Laboratories Improvement Amendments (CLIA) and their associated regulations, and about the availability and utilization of laboratory-developed testing procedures during the 2020 COVID-19 pandemic. The COVID-19 assessment must include information about:
o The average length of time from validation to achieving emergency use authorization (EUA) before and after 29 February 2020;
o The number of patients and samples tested by labs using these procedures; and
o Recommendations to ensure that in future outbreaks, the public health system and clinical laboratories do not encounter delays to testing.
• Expresses the Sense of Congress that labs using lab-developed testing should adhere to personnel requirements under § 353 of the Public Health Service Act, and the federal government should work to:
o ensure that patients receive the most appropriate tests for medical evaluation and treatment;
o ensure that lab-developed testing is accurate, precise, clinically-relevant, and monitored for quality performance;
o enable lab professionals to provide their services without undue restrictions;
o ensure that oversight of lab tests does not limit patient access, impede innovation, constrain flexibility, or limit the sustainability of tests;
o preserve the ability of the laboratory community to provide surge capacity in public health emergencies, including biological, chemical, radiological, and nuclear threats, infectious disease outbreaks, or other emergent situations; and
o safeguard, strengthen, and expand the existing Laboratory Response Network.